MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-04-020

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address subsidence and loosening of the femoral stem at the bone to implant interface.Left femur.Doi: (b)(6) 2019, dor: (b)(6) 2021, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: TRI-LOCK BPS SZ 2 STD OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12584580
• MDR Text Key: 274989998
• Report Number: 1818910-2021-22187
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000730
• UDI-Public: 10603295000730
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-04-020
• Device Catalogue Number: 101204020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 32 +5 BR.; TRI-LOCK BPS SZ 2 STD OFFSET.; ARTICUL/EZE BALL 32 +5 BR; TRI-LOCK BPS SZ 2 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 48